Chemical Mfrs. Ass'n v. EPA

The court upholds the Environmental Protection Agency's (EPA's) decision to require testing of 2-ethylhexanoic acid under Toxic Substances Control Act (TSCA) § 4, ruling that TSCA authorizes EPA to issue a test rule when it finds a more-than-theoretical basis for suspecting an unreasonable risk of injury to health. The court first holds that this case is not moot. Although the chemical industry has now submitted the test data required by the rule, the regulation imposes a continuing duty on chemical manufacturers to notify EPA of exports of the chemical. The court next holds that under TSCA § 4, EPA may find that an unreasonable risk of injury to health may exist if there is a substantial probability of injury, that is, the probability is more than merely theoretical, speculative, or conjectural. Congress did not address this precise issue, and this EPA interpretation is reasonable and consistent with the statutory scheme and legislative history. TSCA § 4 governs testing of chemicals, not their regulation, and a lower threshold of probability is needed here than for actual regulation under § 6. Moreover, TSCA § 4 requires only that an unreasonable risk may exist, and the legislative history indicates that this was a deliberate effort by Congress to focus EPA's attention on chemicals about which not enough is known. The legislative history indicates that even the more stringent factual findings required under § 6 may not have to meet the more-probable-than-not standard. Congress did make clear, however, that EPA must have more than a mere hunch on which to base a TSCA § 4 rule.

The court next holds that EPA may conclude that there is human exposure to the chemical of concern based on inference rather than direct evidence, even in the face of direct evidence to the contrary, so long as the overall evidence supports a more-than-theoretical basis. Congress did not address this issue in the statute or legislative history, and the EPA interpretation is reasonable. Similarly, EPA may issue a test rule under TSCA § 4 whether the human exposure is brief or recurrent, so long as there is a more-than-theoretical basis for concluding that the exposure may present an unreasonable risk of injury. Congress has not addressed this issue, but EPA's interpretation is reasonable in light of TSCA's purposes.

The court next holds that TSCA § 19, which governs judicial review of EPA actions under TSCA, requires a more searching review than normal judicial review under the Administrative procedure Act. The court finds sufficient evidence in the record that there is a more-than-theoretical probability of human exposure in this case, and sufficient evidence that there is a more-than-theoretical probability that this chemical is unreasonably harmful even in brief doses.